Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures

NCT ID: NCT00610701

Last Updated: 2017-07-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate patients with tibial plateau fractures.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to evaluate patients with tibial plateau fractures. The goal is to compare the differences between anteriorly placed (front of leg) femoral external fixator pins and laterally placed (side of leg) femoral external fixator pins.

Specifically, we are evaluating how this placement affects the quadriceps muscle and knee function. The parameters that will be assessed are knee function, pain, and range of motion.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fractures, Closed

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anterior pin placement

Anterior pin placement

Group Type EXPERIMENTAL

Anterior pin placement

Intervention Type DEVICE

Anteriorly-placed (front of the leg) femoral external fixator pins

Lateral pin placement

Lateral pin placement

Group Type EXPERIMENTAL

Lateral pin placement

Intervention Type DEVICE

Laterally-placed (side of the leg) femoral external fixator pind

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anterior pin placement

Anteriorly-placed (front of the leg) femoral external fixator pins

Intervention Type DEVICE

Lateral pin placement

Laterally-placed (side of the leg) femoral external fixator pind

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years of age and above (adult population)
* All open and closed tibial plateau fractures

Exclusion Criteria

* 17 years of age and less (pediatric population)
* Quadriplegic patients
* Vascular Injury to Extremity
* Ipsilateral femur fractures
* Ipsilateral Hip fractures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Brett Crist

Associate Professor, Co-Director of Trauma Services, Co-Director of Trauma Fellowship, Department of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Brett Crist, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Missouri

Columbia, Missouri, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB 1059937

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

THP Hip Fracture Plating System Study
NCT03870477 TERMINATED NA